Pharmaceutical composition for treatment of emiction disorders caused by benign prostate hyperplasia (BPH) and the method

ABSTRACT

A pharmaceutical composition with higher curative effect on benign prostate hyperplasia and emiction disorders is disclosed. It uses plants such as ginseng and gingko as well as cassia twig, cinnamon and liquorices both for food and medicine as raw materials. These raw materials are decocted or extracted separately in ethanol solution or water, then concentrated and dried to make the said pharmaceutical composition. Because this pharmaceutical composition is not toxic and has no side effect, it can be prepared as a medicament and healthy food to treat and improve benign prostate hyperplasia and emiction disorders caused by benign prostate hyperplasia.

TECHNICAL FIELD

This Invention relates to a kind of pharmaceutical composition with itsmain efficacy for improvement and treatment of emiction disorders causedby benign prostate hyperplasia (BPH). It can be used as medicament andhealthy food.

This Invention also relates to a preparation method of thepharmaceutical composition with its main efficacy for improvement andtreatment of emiction disorders caused by benign prostate hyperplasia(BPH).

BACKGROUND OF THE INVENTION

The emiction disorder caused by benign prostate hyperplasia (BPH) is akind of familiar and frequently-occurring disease that harms anddistresses the health of old and middle-aged men. Especially with theincrease of aged population in recent years, its incidence risescontinuously. Taking the United States of America as an example, almostone third of American adult men have BPH diseases statistically. InChina, the BPH incidence trends to go up swiftly. According to theinvestigation, up to now the incidence of Chinese men above 41 years oldhas risen from 6.6% in 1936 to 30.5%.

The modern medical studies have proven that there are two factorsleading to lower urethra hamperness caused by prostate hypertrophy, thatis, dynamic and static factors. At present, two major categories ofmedicaments are used clinically to treat BPH: α1-adrenal receptorblocking agent and 5α-reductase inhibitor (antiandrogen). The α1-adrenalreceptor blocking agent acts on smooth muscles of prostate gland andneck of bladder to reduce their tension. Thus the dynamic factor ofblocked exit of urinary bladder is released to abate or remove theclinical symptoms. Its representative medicaments are HARNAL, TERAZOSIN,etc. The 5α-reductase inhibitor inhibits Prostate Hyperplasia withinhibiting testosterone from being transformed into DHT, with itsrepresentative medicaments such as PROSCAR. These two kinds ofmedicaments have obvious curative effect in treatment and improvement ofBPH dysuria, but they have also different degrees of side effects forpatients. The frequently used compound medicaments of pure plants forclinical treatment of BPH are CEFASABAL and PROSTAT pollen preparation.The features of these medicaments are secure, but usually with longperiod of treatment, e.g., with poor immediate curative effect.

From the viewpoint of the Chinese Traditional Medicine, the emictiondisorder caused by BPH belongs to the category of dysuria and blocking.The dysuria said in the Chinese Traditional Medicine refers to difficultemiction, slim and fragile urine line and blocked urine. When man pissesuneasily and difficultly with light degree of seriousness, it isdysuria. When man can not piss or it is blocked with a full lowerabdomen and acute degree of seriousness, it is called blocking. Themedical principle of the compound preparation of Chinese traditionalmedicaments for treatment of BPH is a multiple targeting and multipledirecting treatments. Its advantage is that patients are treated as awhole and it is safe. But its shortcoming is as same as the compoundmedicaments of pure plants in the modern medicine.

In the prior art, the Chinese Patent No. 98113889.6 describes a kind ofcapsule and its preparation method. With that method, the raw materialssuch as rough gentian, dried rehmannia root, Tuckahoe, celery wormwood,root of Chinese thorowax, tulip, cordate houttuynia and devilpepper aredecocted in 8-fold water for 2 hours first, and the decoction isfiltered. Secondly, it is decocted in 5-fold water for a hour, and thedecoction is filtered. Thirdly, it is decocted in 3-fold water for ahour, and the decoction is filtered. Then the three decoctions arecombined, decompressed, and concentrated as a dry extract. After it isdried, it is comminuted and put in capsules. It has effects of clearingaway the heat-evil and expelling superficial evils, relieving rheumaticpains; colds, etc and reducing swellings, relaxing the liver-fire anddispelling melancholy, and activating blood circulation to dissipateblood stasis. It is applicable for diseases such as acute and chronicprostatitis, prostate hypertrophy, etc. In the clinical observation, ithas obvious curative effects, and the symptom of dysuria is obviouslyimproved. And its efficiency rate reaches 90%. But its prescription isrelatively complicated, especially with uncertain effect on emictiondisorders.

SUMMARY OF THE INVENTION

In order to overcome the shortcomings in the prior art, the object ofthis invention is to provide a kind of pharmaceutical composition withits main efficacy for improvement and treatment of emiction disorderscaused by benign prostate hyperplasia (BPH), especially a kind ofmedicament of plants, which can be used both as medicament and healthyfood.

This kind of pharmaceutical composition made of raw materials both asmedicament and food has no noxious effect (side effect) and can be takenas a medicament for treatment of BPH emiction disorders for a long time.And it can also be used as healthy food for antiaging immunity-raisingpurposes.

Based on the principles, methods, prescriptions and medicaments aboutdysuria and blocking in the Chinese traditional medicine and combinedwith treatment mechanism of the modern medicine, the solution of thepharmaceutical composition in this invention is researched and developedand is a kind of Chinese medicament of pure plants with its mainefficacy for improvement and treatment of emiction disorders caused bybenign prostate hyperplasia (BPH). Its features are obvious curativeeffect and safe with strong immediate curative effect. It can initiallyimprove the subjective and objective body symptoms of BPH patients onlyafter it is taken for a week. When taking for a long time, it can alsoraise immunity and antiaging capability of patients.

The other object of this invention is to provide a preparation method ofthe above mentioned pharmaceutical composition with its main efficacyfor improvement and treatment of emiction disorders caused by benignprostate hyperplasia (BPH).

In order to reach the aim in this invention, this invention provides thefollowing technical solution.

In the first embodiment, this invention refers especially to apharmaceutical composition with its main efficacy for improvement andtreatment of emiction disorders caused by benign prostate hyperplasia(BPH), characterized by comprising 9-45 shares of Ginseng and 20-100shares of core of Gingko, preferably 18-36 shares of Ginseng and 40-80shares of core of Gingko based on the weight ratio.

The said pharmaceutical composition is more preferably prepared with thecomponents with the weight ratio of 27 shares of Ginseng and 60 sharesof core of Gingko.

In the second embodiment, 2-30 weight shares of cinnamon and 2-10 sharesof liquorices can be further included in the pharmaceutical compositionwith its main efficacy for improvement and treatment of emictiondisorders caused by benign prostate hyperplasia (BPH) to enhance theanti-inflammatory and inhibitive effect on prostate hypertrophy.

In the third embodiment, on the basis of the second embodiment, 6-12weight shares of cassia twig can be further added in the pharmaceuticalcomposition with its main efficacy for improvement and treatment ofemiction disorders caused by benign prostate hyperplasia (BPH) tostrengthen the diuretic effect of the pharmaceutical composition in thisinvention.

The said pharmaceutical composition in this invention contains thepharmaceutically acceptable carriers or additives and the saidcomposition can be any pharmaceutical form, preferably powder ortablets.

This invention also directs to an extract of the invented pharmaceuticalcomposition with its main efficacy for improvement and treatment ofemiction disorders caused by benign prostate hyperplasia (BPH). The saidextract is obtained with the following method, comprising:

-   1. soaking and extracting 9-45 weight shares of ginseng in ethanol    or water, following by separation and purification by means of    chromatography and dry to get the first extract;-   2. soaking and extracting 20-100 weight shares of core of gingko in    ethanol solution or water, following by separation and purification    by means of chromatography and dry to get the second extract;-   3. mixing the first extract obtained from the step 1 and the second    extract obtained from the step 2 following by crushing and sieving    to get the invented extract.

In the above mentioned method, 18-36 weight shares of ginseng and 40-80weight shares of core of gingko are preferable, 20 weight shares ofginseng and 60 weight shares of core of gingko are more preferable.

In the above mentioned method, the extract out of the water or ethanolsolution of 2-30 weight shares of cinnamon and 2-10 weight shares ofliquorices can also be added.

In the above mentioned method, the extract out of the water or ethanolsolution of 6-12 weight shares of cassia twig can also be added.

The said extract can be processed as any types of medicament inpharmacy. The said extract can contain the pharmaceutical acceptablecarriers or additives.

In addition, the present invention also relates to a method forpharmaceutical extracts with its main efficacy for improvement andtreatment of emiction disorders caused by benign prostate hyperplasia(BPH). The method comprises the following steps of:

-   1. soaking and extracting 9-45 weight shares of ginseng in ethanol    or water, following by separation and purification by means of    chromatography and dry to get the first extract;-   2. soaking and extracting 20-100 weight shares of core of gingko in    ethanol solution or water, following by separation and purification    by means of chromatography and dry to get the second extract;

3. mixing the first extract obtained from the step 1 and the secondextract obtained from the step 2 following by crushing and sieving toget the invented extract.

In accordance with the second embodiment of this invention, 2-30 weightshares of cinnamon and 2-10 weight shares of liquorices are soaked andextracted in water or ethanol solution, concentrated and dried to getextract. Then the obtained extract is further crushed with the first andsecond extracts obtained in Step 1 and 2 together to get the extract ofpresent invention.

In accordance with the third embodiment of this invention, 6-12 weightshares of cassia twig are in water or ethanol solution extracted,concentrated and dried to obtain another extract. Then it is crushedwith the extract of this invention obtained in the second embodimenttogether to get the other extract of this invention.

In addition, the present invention also concerns a method, by whichextracts are made for a kind of pharmaceutical composition with its mainefficacy for improvement and treatment of emiction disorders caused bybenign prostate hyperplasia (BPH). The method comprises the followingsteps, characterized by that 9-45 weight shares of ginseng, 20-100weight shares of core of gingko, 6-12 weight shares of cassia twig, 2-30weight shares of cinnamon and 2-10 weight shares of liquorices aredecocted in water or ethanol solution to obtain their separate extracts.And the separated extracts are concentrated separately to obtain theirpaste extracts. Then they are dried separately to obtain the water orethanol extracts followed by mixing together and crushed.

In other words, it is well known by all the skilled person in the artthat all the raw materials said in this invention can be extracted withthe known methods to prepare and obtain their own dry extractsseparately. Then after they are dried, crushed, sifted out and mixed,the mixture made of all the raw materials in this invention is obtained.

According to the present invention, ginseng, its original plant is Panaxgineng C. A. Mey, and its rootstock can be used. According to differentprocessing methods, the medical commercial garden ginsengs, also calledthe seedling ginsengs, include red ginseng, strake ginseng, sugar-dippedginseng, white ginseng, sun-dried ginseng, suncured white ginseng root,nipped ginseng and Dali ginseng. Additionally, it can include wildginseng, migrated ginseng, Korean ginseng and Korean red ginseng.

The core of gingko, its original plant is Ginkgo biloba L. The medicalpart used in this invention is its dried seeds without their crusts

The cassia twig is the young twig of the Cinnmomum cassia Presl.

The cinnamon is the dried tree or twigs bark of the Cinnmomum cassiaPresl.

The liquorices are the roots and root-shaped stems of the Glycyrrhizauralensis Fisch.

The pharmaceutical composition or extracts of this invention can be usedto make healthy food or food complements.

The pharmaceutical composition or extracts of this invention can be usedas a medicament with its main efficacy for improvement and treatment ofemiction disorders caused by benign prostate hyperplasia (BPH). It hasantiaging functions. When man takes it for a long time, it can not onlyimprove emiction disorders, but also enhance human immunity. Thepharmaceutical composition or extracts have the following features andadvantages:

-   1. The raw materials of the pharmaceutical composition or extracts    said in this Invention are all natural edible plants both for    medicaments and food. All the components apply with the regulations    of the “Management Methods of Healthy Food” and the “Medicine Act”    of the PRC. They have no toxic or side effect. And man can take it    for a long time.-   2. In the field of improvement and treatment of emiction disorders    caused by benign prostate hyperplasia (BPH), the pharmaceutical    composition or extracts in this invention has obvious efficacy and    strong immediate curative effect. It can initially improve the    subjective and objective body symptoms of BPH patients only after it    is taken for a week. When it is taken for a long time, it can also    raise immunity and antiaging capability of patients.-   3. It has antiaging functions. When man takes it for a long time, it    can not only improve emiction disorders, but also enhance human    immunity.-   4. The pharmaceutical composition or extracts has not only proven in    human and animal tests that it can improve and treat effectively    emiction disorders caused by benign prostate hyperplasia (BPH), but    also the contents and action mechanism of its main functional    factors (ginseng saponin, cassia aldehyde, etc.) have been found    out.-   5. The pharmaceutical composition or extracts need not to be    decocted with easy transportation and medicine-taking. It applies    with the regulations of the Health Act of the PRC.-   6. The pharmaceutical composition or extracts have the potential    values for further development of series of products (food, healthy    food and medicaments).

The application of the pharmaceutical composition or extracts are givenbelow:

-   1. This product can be used as antiaging food and healthy food that    improve emiction disorders caused by benign prostate hyperplasia    (BPH) and enhance human immunity.-   2. This product can be used as medicament that improves and treats    emiction disorders caused by benign prostate hyperplasia (BPH)

DESCRIPTION OF THE DRAWINGS

FIG. 1 describes the processing procedures of this invented method.

FIG. 2 describes another processing procedure of this invented method.

FIG. 3 describes another processing procedure of this invented method.

DETAILED DESCRIPTION OF THE INVENTION

In combination with the FIGS. 1, 2 and 3, the present invention isexplained in details as follows.

EXAMPLE 1

Referring to FIG. 1, 27 kg of ginseng was soaked and extracted in 70%ethanol solution. And then it was chromatographed, purified and dried toget the ethanol extract. 60 kg core of gingko was decocted in water,filtered, concentrated and dried to get the water dry extracts. Theethanol extract and water dry extract obtained in the above mentionedsteps were mixed together and crushed, sifted with a 80-mesh screen toobtain the extract of the present invention.

EXAMPLE 2

Repeating the same procedures in Example 1 except that 9 kg of ginsengand 20 kg of core of gingko were soaked and extracted in the ethanolsolution separately.

EXAMPLE 3

Repeating the same procedures in Example 1 except that 45 kg of ginsengand 100 kg core of gingko were decocted in water separately.

EXAMPLE 4

Referring to FIG. 1, 27 kg of ginseng was soaked and extracted in 70%ethanol solution. And then it was chromatographed, purified and dried toobtain ethanol extract.

60 kg of core of gingko, 3 kg of cinnamon, 3 kg of liquorices and 9 kgof cassia twig were decocted in water, filtered, concentrated and driedto obtain dry water extracts.

The ethanol and dry water extracts obtained in the above mentioned stepswere mixed together and crushed, sifted with a 80-mesh screen to obtainthe extract of the invention. The composition of this invention wasprepared directly into capsules with the method known by person skilledin the art.

EXAMPLE 5

Repeating the same procedures in Example 4 except that 45 kg of ginseng,100 kg core of gingko, 2 kg of cinnamon, and 2 kg of liquorices wereextracted in ethanol solution or water separately. Then they were mixedand crushed to obtain the extract of the invention.

EXAMPLE 6

Repeating the same procedures in Example 4, except that 9 kg of ginseng,20 kg of core of gingko, 30 kg of cinnamon, and 10 kg of liquorices wereextracted in ethanol solution or water separately. Then they were mixedand crushed to obtain the extract of the invention. The composition ofthe invention was prepared directly into powder with the method known byperson skilled in the art.

EXAMPLE 7

Repeating the same procedure in Example 6 except that 12 kg of cassiatwig was added.

EXAMPLE 8

Repeating the same procedures in Example 5 except that 6 kg of cassiatwig was added.

EXAMPLE 9

Referring to FIG. 3, 27 kg of ginseng was soaked and extracted in 70%ethanol solution. And then it was chromatographed, purified and dried toobtain the ethanol extract. 60 kg of core of gingko was soaked andextracted in water. It was filtered, concentrated, and dried to obtainthe dry water extract. Then the ethanol and dry water extracts obtainedin the above mentioned steps were mixed and crushed to obtain theextract.

24 kg of cinnamon and 6 kg of liquorices were mixed and decocted in 95%ethanol solution. After it was filtered and concentrated, it is absorbedwith a proper amount of officinal calcium hydrogen phosphate, and thendried to obtain the dry ethanol extract.

The dry ethanol extract of ginseng and the dry water extract of core ofgingko obtained in the above steps were mixed with the dry ethanolextracts of cinnamon and liquorices together, crushed and filtered with80-mesh screen to obtain the extract said in this invention. Thecombination or composition of this invention was prepared directly intopowder with the method known by person skilled in the art.

EXAMPLE 10

Again referring to FIG. 3, repeating the same procedures in Example 9except that 18 kg of ginseng, 40 kg of core of gingko, 2 kg of cinnamonand 2 kg of liquorices were decocted and extracted in water.

The dry water extracts of ginseng and gingko were dried together withthe dry water extracts of cinnamon and liquorices to make the dryextract of the combination.

EXAMPLE 11

27 kg of ginseng, 60 kg of core of gingko, 9 kg of cassia twig, 3 kg ofcinnamon and 3 kg of liquorices were taken. Then the said ginseng,gingko, cassia twig, cinnamon and liquorices were decocted in water or70% ethanol solution and filtered separately to obtain their ownextracts. They were concentrated to obtain their dry extracts, and thenwere dried to obtain their own dry water or ethanol extracts separately.Finally, the obtained dry extracts were crushed and filtered with an80-mesh screen to be mixed together to obtain the extract of theinvention.

EXAMPLE 12

9 kg of ginseng and 20 kg of core gingko were taken. With the methodknown by the person skilled in the art, they were directly crushed andfilter with an 80-mesh screen to obtain the pharmaceutical compositionof the invention. Accordingly with the method known by the personskilled in the art, they were directly pressed and made into tablets.

EXAMPLE 13

45 kg of ginseng, 100 kg of core of gingko, 30 kg of cinnamon and 10 kgof liquorices were taken. With the method known by the person skilled inthe art, they were directly crushed and filtered with an 80-mesh screento obtain the pharmaceutical composition of the invention. Then with themethod known by the person skilled in the art, they were directlypressed and made into tablets.

EXAMPLE 14

Repeating the same procedures in Example 13 except that 12 kg of cassiatwig was added, crushed and sifted out.

EXAMPLE 15

Repeating the same procedure in Example 13 except hat 18 kg of ginseng,40 kg of core of gingko, 3 kg of cinnamon, 4 kg of liquorices and 6 kgof cassia twig were crushed into powder. Then with the method known bythe person skilled in the art, the composition of the invention is madeinto capsules.

EXPERIMENTING EXAMPLE 1

Impacts on prostate hyperplasia of rats caused by testosteronepropionate by medicaments of anti prostate hyperplasia and the extractsof this invention were done as below.

Experimental Materials

Medicaments:

-   1. PROSCAR: tablets, produced by Merck & Co., Inc., (UK) Co. The    medicament was prepared into 0.5 mg/ml medicament.-   2. Saw Palmett tablets, produced by Zhejiang Conba Pharmaceutical    Co. Ltd. It was prepared with distilled water into 0.5 mg/ml medical    liquid.-   3. Longbishu Capsules: produced by SHIJIAZHUAN KEDI Pharmaceutical    Co., Ltd. It was prepared with distilled water into 0.18 g/ml    medical liquid.-   4. The extract was taken from Example 9. The extract was prepared    into 6 g/ml medical liquid.-   5. Estradiol Benzoate Injection-   6. Testosterone propionate Injection    Test Method and Results

The 130 g-150 g male Wistar rats were taken as test animals andanaesthetized with ether. Both of their testis were removed under axenicconditions and bred for a week after operation. The rats were divided atrandom into 6 groups, 6 in each group. All groups of animals were hypedwith 5 mg/Kg testosterone propionate dissolved in prepared peanut oilper day. And they were simultaneously medicated, that is, the contrastgroups were drunk by force with physiological salt solution. Themedicine-taking groups were drunk by force with 5 mg/Kg PROSCAR, 5 g/KgSaw Palmetto, 1.8 g/Kg longbishu, 6 g/Kg extract obtained from Example 9in this invention, with the medicine-taking 1 ml/100 g volume; and forhypodermic injection of 50 μg/Kg estradiol benzoate, the volume was 0.05ml/Kg, once a day and continuously for 30 days. In 24 hours after thelast medicine-taking, all the rats were killed. The whole prostateglands were anatomized. The prostate glands were placed in formalin. Allthe fat were removed away after the prostate glands were taken out. Theliquid on the surface was dried with filter papers. They were weighedwith a tissue balance to calculate the weight (factors) of prostateglands. Table 1 shows the results. TABLE 1 Impact on Prostate GlandFactors (mg/100 g) of Rats by medicaments of anti prostate hyperplasia x± SD Sum of three lobes Dosage/volume (anterior, g/kg Number head andweight of Anterior Inhibition posterior Inhibition Medicament g/kganimals lobe rate % lobes) rate % Contrast — 10 284.7 ± 75.7  721.2 ±129.7 group estradiol 50 μg/Kg 10 180.1 ± 55.8 36.7** 585.3 ± 80.518.8** benzoate PROSCAR 5 mg/Kg 10 164.2 ± 31.4 42.3** 453.4 ± 59.137.1** Saw Palmett 5 g/Kg 10 250.6 ± 40.9 11.9** 656.5 ± 88.1 4.7**Longbishu 1.8 g/Kg 10 231.4 ± 37.0 18.7** 650.2 ± 68.1 9.8** The extract6 g(crude 10 190.2 ± 30.3 33.2** 497.9 ± 81.1 30.9** drug)/KgNote:compared with the contrast groups:*P < 0.05,**P < 0.01

EXPERIMENTING EXAMPLE 2 Study on the Action of Anti Prostate Hyperplasiaby the Extract in this Invention

In order to evaluate the action of anti prostate hyperplasia by theextract in this Invention, the anti-inflammatory action of the extractin this intention and its impact on prostate hyperplasia caused byTestosterone Propionate were observed in this experiment.

Experimental Materials

1. Animals: 1) Wistar rats and 2) mice of Kunming origin

2. Medicaments:

2.1 The extract obtained in Example 9 in this invention

2.2 Estradiol benzoate Injection

2.3 Testosterone Propionate injection

2.4 Hydrocortisone acetate injection

Experimental Method and Results

1. Impact on Otic Swelling caused by Mixed Inflammatory Solution ofCroton Oil

60 18-22 g male mice were selected and divided in 6 groups randomly, 10in each group: a contrast group of physiological salt solution, a groupof hydrocortisone, a group of Saw Palmett, and three dosage groups ofthe extract obtained in Example 9 in this invention (1.5, 3.0 and 6.0g/kg). They were drunk by force with the medicaments in the stomachs,once a day, and continuously for 5 days. After the last medicament, themixed inflammatory solution of croton oil (2% croton oil, 20% anhydrousethanol, 5% distilled water and 73% ether) was applied on the both frontand rear sides of the left ears of animals, 0.05 ml each mouse. Fourhours after inflammation, the mice were killed with a disjointedcervical vertebra method. The two ears were cut along the auriclebaseline. The equal parts of the two ears with the same area were cutoff and weighed on weighing scales to test twisting force. When theweight of the right ear was subtracted from the weight of the left earof each mouse, it got the swelling degree. The swelling degrees betweenthe contrast groups and the medicine-taking groups were processedstatistically; the swelling inhibition rate was got. Table 2 shows theresults. TABLE 2 Impact on otic swelling degrees caused by mixedinflammatory solution of croton oil by the extract in this InventionSwelling degree Inhab- Number of (mg) itation Groups Dosage animals (x ±SD) P rate % Contrast 10 17.85 ± 2.05 group The said 1.5 g/kg 10 15.25 ±2.26 <0.05 14.56 extract The said 3 g/kg 10 13.10 ± 1.45 <0.01 26.61extract The said 6 g/kg 10 11.55 ± 2.38 <0.01 35.29 extract Saw Palmett2.5 g/kg 10 12.65 ± 1.30 <0.01 29.13 Hydrocortisone 20 mg/kg 10  9.50 ±2.93 <0.01 46.77

The results have shown that the high, middle and low dosages of theextract in this invention can all obviously reduce the swelling degreesof mouse otic inflammation caused by the mixed inflammatory solution ofcroton oil. The extract in this Invention has an anti-inflammatoryaction.

EXPERIMENTING EXAMPLE 3 Impact on Permeability of Mice Celiac CapillaryVessels

The same experimental materials and animals as in Experimenting Example2 were used. But it was different that 60 18-22 g male mice wereselected and divided in 6 groups in accordance with their weight, 10 ineach group: a contrast group of physiological salt solution, a group ofhydrocortisone, a group of Saw Palmett, and three dosage groups of theextract obtained in Example 9 in this invention (1.5, 3.0 and 6.0 g/kg).They were drunk by force with the medicaments in the stomachs once aday, and continuously for 5 days. One hour after the last medicament,they were intravenously injected with 0.5% Evans blue in a 5 ml/kgdosage. After 5 minutes, 0.7% acetic acid in a dose of 10 ml/mg wasinjected in their abdomens. After 30 minutes, they were killed with adisjointed cervical vertebra method. Their abdomens were washed manytimes with distilled water. The washing solution was changed to thetotal amount of 10 ml/mg, and 0.1N NaOH 0.1 mL was added. After it wasplaced for 30 minutes, the light density of mice celiac transudate wasmeasured with a colorimetry of a 721 spectrophotometer. Table 3 showsthe results. TABLE 3 impact on permeability of capillary vessels by theextract in this Invention Number Evans blue Inhibi- of transudate (ODtion rate Groups Dosage animals

x ± SD) P (%) Contrast 10 0.166 ± 0.04  The said 1.5 g/kg 10 0.133 ±0.030 >0.05 19.87 extract The said 3 g/kg 10 0.117 ± 0.031 <0.01 29.52extract The said 6 g/kg 10 0.100 ± 0.027 <0.01 39.75 extract Saw Palmett2.5 g/kg 10 0.122 ± 0.033 <0.05 26.51 Hydrocortisone 20 mg/kg 10 0.092 ±0.019 <0.01 44.58

The results have shown that the high, middle and low dosages of theextract in this invention can all obviously reduce the permeability ofmice celiac capillary vessels and make the Evans blue transudatedecline. It shows that the extract in this Invention has ananti-inflammatory action.

EXPERIMENTING EXAMPLE 4 Impact on Tampon Granuloma of Rats

The same experimental materials and animals as in Experimenting Example2 were used. But it was different that 60 150-180 g male rats were used.Under the ether anaesthesia and normal disinfection, two ±1 mgsterilized tampons were embedded under the inguinal skins on the bothsides. On the same day of operation, the 60 rats were randomly dividedin 6 groups, 10 in each group: a contrast group of physiological saltsolution, a group of hydrocortisone, a group of Saw Palmett, and threedosage groups of the extract obtained in Example 9 in this invention.They were drunk by force with the medicaments in the stomachs once aday, and continuously for 7 days. On the eighth day, they were killedwith a disjointed cervical vertebra method. The tampons were taken outand placed in a 60° C. oven for 12 hours and then weighed. Table 4 showsthe results. TABLE 4 impact on tampon granuloma of rats Weight of tamponNumber granuloma of (mg Inhibition Groups Dosage animals x ± SD) P rate% Contrast 10 45.95 ± 9.03 The said 1.5 g/kg 10 40.30 ± 7.32 >0.05 12.30extract The said 3 g/kg 10 38.05 ± 6.17 <0.05 17.19 extract The said 6g/kg 10 32.15 ± 5.41 <0.01 30.03 extract Saw Palmett 2.5 g/kg 10 42.30 ±6.36 >0.05 7.94 hydrocortisone 20 mg/kg 10 26.45 ± 2.61 <0.01 42.43

The results have shown that the high and middle dosages of the extractin this Invention can all obviously inhibit the hyperplasia of tampongranuloma of rats. t shows that the extract in this invention has ananti-inflammatory action.

EXPERIMENTING EXAMPLE 5 Impact on Rat Prostate Hyperplasia caused byTestosterone Propionate

The same experimental materials and animals as in Experimenting Example2 were used. But it was different that 60 130-150 g male Wistar ratswere used. Under the conditions of ether anaesthesia and sterilization,the testis of both sides were removed. They were bred for a week afterthe operation. The rats were randomly divided in 5 groups, 10 in eachgroup. Each group of animals were hyped with 5 mg/kg testosteronepropionate dissolved in prepared oil once a day. And at the same timethey were treated with medicaments. For the contrast group, they weredrunk by force with physiological saline solution; for the medicine-fedgroup, they were drunk by force with 1.5, 3 and 6 g/kg extract obtainedin Example 9 in this invention separately with a medicine-taking volumeof 1 m/100 g. For the positive contrast group, they were hyped with 50ug/kg estradiol benzoate with a volume of 0.05 ml/100 g, once a day andcontinuously for 30 days. After the last medicament, the rats werekilled. The whole prostate glands were anatomized. The prostate glandswere placed in formalin. All the fat was removed away after the prostateglands were taken out. The liquid on the surface were dried with filterpapers. And the prostate glands were placed in 70% ethanol and fixed for24 hours. Then they were taken out and placed on filter papers. Theanterior, head and posterior lobes of prostate glands were separated andweighed a weighing scale to test twisting force to calculate the factorsof all the lobes of prostate glands. The transverse diameter, diameterand height of the anterior lobes of prostate glands were measured with atwo-foot vernier. When the three dimensions multiply, the volume of theanterior lobe of a prostate gland was got. Lastly, all the anteriorlobes were examined with tectology, and the diameter of prostate glandcavity and the height of glandular epithelium cells were measured. Thenon-pairing t examinations among the groups were made for all theindexes. The obviousness of average difference were compared between themedicine-taking and contrast groups. Table 5 and 6 show the results.

1. Impact on Weight of Prostate Glands of Rats

30 days after the rats took the medicament, in comparison with thecontrast group, the 1.5 g, 3 g and 6 g crude drug/kg of the extract inthis invention have the inhibition rates of 23.2% (P<0.01), 31.26%(P<0.01), and 34.46% (P<0.01) for prostate anterior lobe separately, andthe inhibition rate of estradiol is 35.3% (P<0.01); the inhibition ratesfor head lobes are 13.5%, 36.5% (P<0.01), and 46.0% (P<0.01) separately,the group of estradiol is 30.2% (P<0.05); the inhibition rates forposterior lobe are 9.6%, 15.3%, and 20.8% separately, the inhibitionrate of estradiol is 12.5%. The results have shown that the extract inthis invention has an obvious inhibitive action on the weight ofanterior and head lobes with no obvious influence on posterior lobe.

2. Impact on the Volume of Prostate Anterior Lobe of Rats TABLE 5 Impacton rat prostate factors (mg/100 g) of all lobes by the extract in thisinvention x ± SD Dosage Number of Groups (g/Kg body weight) animalsAnterior lobe Head lobe Rear lobe Contrast 10 196.7 ± 41.1  73.4 ± 22.3 54.1 ± 12.8 The said 1.5 g/kg 10 151.0 ± 28.1** 63.5 ± 7.3   48.9 ± 11.9extract The said 3.0 g/kg 10 135.2 ± 40.9** 46.6 ± 16.5** 45.8 ± 15.3extract The said 6.0 g/kg 10 128.9 ± 26.3** 39.6 ± 13.5** 42.7 ± 12.3extract Estradiol 50 μg/kg 10 127.2 ± 23.4** 51.2 ± 10.7*  47.3 −+ 14.4benzoateNote:in comparison with the contrast group:*P < 0.05,**P < 0.01

30 days after the rats took the medicament, in comparison with thecontrast group, the 1.5 g, 3 g and 6 g of crude drug/kg of the extractin this invention have the inhibition rates of 18.2%, 31.1% (P<0.01),and 40.3% (P<0.01), and the inhibition rate of estradiol is 45.5%(P<0.01). The results have shown that the extract in this Invention hasan obvious inhibitive action on the volume of prostate gland. TABLE 6Impact on the volume of prostate anterior lobe of rats by the extract inthis invention X ± SD Volume of anterior Dosage (g/kg Number lobeMedicament weight) of animals (cm3) Contrast group 10 0.77 ± 0.21  Thesaid extract 1.5 g/kg 10 0.63 ± 0.17  The said extract 3.0 g/kg 10 0.53± 0.13** The said extract 6.0 g/kg 10 0.46 ± 0.13** Estradiol 50 μg/kg10 0.42 ± 0.12**Note:in comparison with the contrast group:*P < 0.05,**P < 0.01

3. Impact on the Diameter of Prostate Gland Cavity and the Height ofGlandular Epithelium Cells of Rats

30 days after the rats took medicament continuously, the microscopicexamination has shown that the prostate gland body of the anterior, headand posterior lobes has obvious hyperplasia with enlarged acinus. Therewere epithelioid papillas going into gland cavity. On the hyperplasticglandular epithelium, an active excreting activity could be seen. Theglandular epithelium cells appeared in high column-form or multi-layerform without clear cell boundaries. The nucleus was placed on the basewith parts of cell plasm in a grain form. The glandular cavity was fullof secretion. The hyperplasia of connective tissue between acini canalso be observed. The histological changes in the medicine-taking groupswere nearly the same. The hyperplasia of anterior and head glandularbody was not so obvious as the contrast group. The hyperplasia ofposterior lobe could still be observed with the similar pathologicchanges as in the contrast group. But in comparison with the contrastgroup, the extract in this invention can obviously inhibit thehyperplasia of the diameter of the glandular cavity of prostate anteriorand head lobes. The estradiol can also obviously inhibit the hyperplasiaof the diameter of prostate anterior and head glandular cavity. In allthe groups, no obvious influence was observed on the diameter ofposterior glandular cavity and the height of glandular epithelium cellsof all the lobes. The results have shown that the extract in thisinvention can inhibit hyperplasia of diameter of prostate anterior andhead glandular cavity.

EXPERIMENTING EXAMPLE 6 Impact on Prostate Hypernlasia caused byImplantation of Urine Genital Sinus of Mice

60 30-35 g male mice with the age of 7-10 weeks were selected. Under theinjected celiac anaesthesia with 50 mg/kg pentobarbital, the inferiorbelly was cut open and the prostate gland was separated carefully. Asmall hole was made in the celiac prostate gland with a needle. Thenthree urine genital sinus tissues with 16-day fetal age were implantedin the celiac anterior lobe. Another mouse was taken and its celiacprostate gland was probed twice with a needle as a blank contrast offalse operation. Then the belly was sutured. On the same day, taking the10 animals as the blank contrast group of false operation, the other 50animals were divided in 5 groups, 10 in each group: a contrast group,three dosage groups of the extract in Example 9 in this invention, and agroup of positive contrast Saw Palmett. They were drunk by force withthe medicament in the stomachs once a day and continuously for 30 days.After the last medicament, the mice were killed and paunched. Theprostate glands were taken out and weighed with a tissue scale. Theresults were used to examine the obviousness of difference between themedicine-taking group and the contrast group with the t examinationmethod and to calculate the inhibition rate. (see Table 7) TABLE 7Impact on prostate hyperplasia caused by implantation of urine genitalsinus of mice by the extract in this invention Weight of prostate glandNumber of (mg/10 g Inhibition Groups Dosage animals x ± SD) P rate %Blank 10 17.9 ± 6.32 contrast Contrast 10 63.4 ± 11.4 The said 1.5 g/kg10  53 ± 7.4 <0.05 16.4 extract The said 3 g/kg 10 45.8 ± 4.8  <0.0127.8 extract The said 6 g/kg 10  41 ± 6.6 <0.01 35.3 extract Saw Palmett2.5 g/kg 10 49.6 ± 8.6  <0.01 21.8

The experimental results have proven that the prostate hyperplasia isobviously caused with the implantation of urine genital sinus of mice.30 days after the mice took the extract in this Invention, the high,middle and low dosage groups can reduce the weight of prostate glands ofmice with obvious difference in comparison with the contrast group. Ithas shown that the extract can obviously inhibit the prostatehyperplasia caused by the implantation of urine genital sinus of mice.

EXPERIMENTING EXAMPLE 7 Curative Effect on Senile BPH Patients with theExtract in this Invention

Method:

In June-August 2002, the inventor treated 46 cases of BPH patients withthe age of above 51-70 with the extract obtained in Example 4 in thisinvention. It was taken with warm water in the morning and evening withan empty stomach in a dose of 1.0 g/tablet, once a tablet, twice a day.They were treated and observed for one week and 4 weeks.

Results:

Patients: The subjective symptoms were obviously improved. One week and4 weeks after the treatment, the IPSS was averagely reduced by 16.6% and30% separately. And the MFR was averagely increased by 14.2% and 33%separately. After four-week treatment, according to the measurement withan ultrasonic wave scanning Type B, the average residue urine wasreduced by 36%. The extract in this invention has no impact on the pulseand blood pressure of the patients who take the extract in thisInvention.

CONCLUSION

The extract in this invention is safe and effective for senile BPHpatients. It can make the subjective symptoms and objective bodysymptoms of patients as well as their life improve obviously withoutobvious serious side effect.

1. Data and Methods

1.1 Clinical Data

There were 46 cases of male patients with an age of 51-78, averaging63.2. In accordance with their chief complaints, they suffered fromdysuria. After finger examination of anus, examination with anultrasonic wave scanner Type B, etc., the diseases such as sclerosis ofneurogenic urinary bladder and neck of bladder, carcinoma of prostate,etc. and other diseases that have impact on emiction. In accordance withthe clinical diagnose, they are suffered from BPH: IPSS>22 in average;MFR=10.6 ml/s (one urine volume>152 ml); and bladder residue urine=51.6ml in average in accordance with the ultrasonic wave scanner Type B.

1.2 Treatment Methods

2 weeks before treatment, they were not allowed to take diureticmedicaments. In the treatment, they took the extract in this Invention,once a tablet, twice a day, and they should take it in the morning andevening with a empty stomach and drink warm water together. They weretreated and observed for one week and four weeks. Before the treatment,1 week and 4 weeks after medicament supply, IPSS, urine flow rate,bladder residue urine, pulse and blood pressure were measuredseparately. During the treatment, all the other curative BPH medicamentsand medicaments that have influence on emiction were stopped. The sideeffects were recorded. The examination and evaluation were processedwith the t check statistics.

2. Results

2.1 IPSS Evaluation

Before the treatment, one week and four weeks after the treatment, theaverage IPSS value was 24.6±3.4, 20.5±3.2, 17.2±4.1 in averageseparately. The IPSS values have obvious difference between the valuesof one week and four weeks after the treatment (P<0.01), and the IPSSwas reduced by 16.6% and 30% separately. (see Table 8)

2.2 Maximum Flow Rate (MFR)

Before the treatment, one week and four weeks after the treatment, therecorded MFR was (10.6±4.1)ml/s, (12.1±4.4)ml/s, and (14.1±3.8)ml/sseparately. The difference before and after the treatment was obvious(P<0.01), and the MFR were increased by 14.2% and 33% in averageseparately. (see Table 8)

2.3 Bladder Residue Urine

Before the treatment and one week and four weeks after the treatment, inaccordance with the celiac measurement with a ultrasonic wave scannerType B, the bladder residue urine was (51.6±38)ml, (41±32)ml, and(33±26)m1 separately with obvious difference (P<0.01), and the averageresidue urine was reduced by 20.5% and 36%. (see Table 8)

2.4 Side Effects

Before the treatment, one week and four weeks after the treatment, noobvious changes occurred in the pulse and blood pressure of patients,and also without depressed blood pressure. TABLE 8 Comparison ofimproved urine flow before and after taking the extract in thisinvention Before 1 week after 4 weeks after Time treatment treatmenttreatment P I-PSS value 24.6 ± 3.4 20.5 ± 3.2 17.2 ± 4.1 <0.01 (↓ 16.6%)(↓ 30%) MFR(ml/s) 10.6 ± 4.1 12.1 ± 4.4 14.1 ± 3.8 <0.01 (↑ 14.2%) (↑33%) Residue urine 51.6 ± 38  41 ± 32  33 ± 26 <0.01 (ml) (↓ 20.5%) (↓36%)

3. Discussion

From the viewpoint of the Chinese Traditional Medicine, the emictiondisorder caused by BPH belongs to the category of dysuria and blocking.The dysuria said in the Chinese Traditional Medicine refers to difficultemiction, slim and fragile urine line and blocked urine. When man pissesuneasily and difficultly with light degree of seriousness, it isdysuria. When man can not piss or it is blocked with a full lowerabdomen and acute degree of seriousness, it is called blocking. Based onthe principles, methods, prescriptions and medicaments about dysuria andblocking in the Chinese traditional medicine and combined with treatmentmechanism of the modern medicine, the solution of the pharmaceuticalcomposition in this invention is researched and developed and is a kindof Chinese medicament of pure plants with its main efficacy forimprovement and treatment of emiction disorders caused by benignprostate hyperplasia (BPH). Its features are obvious curative effect andsafe with strong immediate curative effect.

The clinical experiments have shown that the said extract in thisinvention can improve the subjective and objective symptoms of senileBPH patients with its strong immediate curative effect. One week aftertreatment, it can reduce patients' IPSS by 16.6% in average, andincrease patients' MFR by 14.2% in average, and reduce patients' residueurine by 20.5% in average. In addition, side effects occur very rarelywhen the extract of the Chinese traditional medicament is taken to treatemiction disorders caused by BPH.

1-8. (canceled)
 9. A pharmaceutical extract, characterized by that theextract is obtained by the following steps of: soaking and extracting9-45 weight shares of ginseng in ethanol or water, following byseparation and purification by means of chromatography and drying to geta first extract; soaking and extracting 20-100 weight shares of core ofgingko in ethanol solution or water, following by separation andpurification by means of chromatography and drying to get a secondextract; mixing the first extract and the second extract following bycrushing and sieving to get said pharmaceutical extract.
 10. Thepharmaceutical extract of claim 9, wherein said first extract isobtained from 18-36 shares of ginseng and said second extract isobtained from 40-80 shares of core of gingko based on the weight ratio.11. The pharmaceutical extract of claim 9, wherein said first extract isobtained from 27 shares of ginseng and said second extract is obtainedfrom 60 shares of core of gingko based on the weight ratio.
 12. Thepharmaceutical extract of claim 9, further comprising a third extractobtained from the water or ethanol extract from addition of 2-30 sharesof cinnamon and 2-10 shares of liquorices.
 13. The pharmaceuticalextract of claim 9, further comprising a fourth extract obtained fromthe water or ethanol extract from 6-12 shares of cassia twig.
 14. Thepharmaceutical extract of claim 9, wherein the said extract is preparedas any medicament type pharmaceutically.
 15. The pharmaceutical extractof claim 9, comprising pharmaceutically acceptable carriers. 16.(canceled)
 17. A method of preparation of a pharmaceutical extract,comprising the following steps of: soaking and extracting 9-45 weightshares of ginseng in ethanol or water, following by separation andpurification by means of chromatography and drying to get a firstextract; soaking and extracting 20-100 weight shares of core of gingkoin ethanol solution or water, following by separation and purificationby means of chromatography and drying to get a second extract; mixingthe first extract and the second extract.
 18. The method of claim 17,further comprising extracting 2-30 weight shares of cinnamon and 2-10weight shares of liquorices in water or ethanol to have a third extract,and mixing the first extract and the second extract with the thirdextract.
 19. The method of claim 18, further comprising extracting 6-12weight shares of cassia twig in water or ethanol to have a fourthextract, and mixing the first extract, the second extract and the thirdextract with the fourth extract. 20-22. (canceled)
 23. The use of thepharmaceutical extract of claim 9 in preparation of medicament forimprovement and treatment of emiction disorders caused by BHP.
 24. Theuse of the pharmaceutical extract of claim 9 in production of food andhealthy food.
 25. (canceled)
 26. The method of claim 17, wherein saidfirst extract is obtained from 18-36 weight shares of ginseng and saidsecond extract is obtained from 40-80 weight shares of core of gingkobased on the weight ratio.
 27. The method of claim 17, wherein saidfirst extract is obtained from 27 weight shares of ginseng and saidsecond extract is obtained from 60 weight shares of core of gingko basedon the weight ratio.